ARIAD Presents Updated Phase 1/2 Clinical Data on Brigatinib in Patients with ALK+ Non-Small Cell Lung Cancer

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ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced updated clinical data on its investigational tyrosine kinase inhibitor, brigatinib, in patients with advanced malignancies, including anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC), from an ongoing Phase 1/2 trial. This report includes updated data on the brigatinib safety profile and pharmacokinetics (PK) from all patients treated in the trial, with a focus on brigatinib clinical activity in patients with ALK+ NSCLC, including those with intracranial CNS metastases at study entry. The report also details overall survival outcomes of patients in the study.”

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Zykadia Shows High Response Rate Against ALK-Rearranged NSCLC in Clinical Trial

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“Updated results of the phase I ASCEND-1 trial, reported by Kim et al in The Lancet Oncology, indicate that the ALK inhibitor ceritinib (Zykadia) produced high response rates in advanced ALK-rearranged non–small cell lung cancer (NSCLC), including intracranial disease, in both patients with and without prior ALK inhibitor treatment.

“In the open-label trial, 246 patients enrolled from 20 sites in 11 countries in Europe, North America, and Asia-Pacific between January 2011 and July 2013 received oral ceritinib at 750 mg/d. Patients had ALK-rearranged locally advanced or metastatic disease that had progressed despite standard therapy or for which there was no effective standard therapy. A total of 83 patients had received no prior ALK inhibitor treatment, and 163 had received crizotinib (Xalkori), with 5 also receiving alectinib (Alecensa) after crizotinib. In these two groups, 53% and 54% of patients were female, 58% and 66% were white, and 42% and 29% were Asian.”

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Alectinib Highly Active in Advanced ALK-Positive NSCLC

“Alectinib showed promising activity in patients with advanced, crizotinib-refractory, ALK-positive non–small cell lung cancer, according to results of a global phase 2 study.

“The regimen also appeared well tolerated.

“In December, the FDA granted accelerated approval to alectinib (Alecensa, Genentech) — an oral, small molecule, ATP-competitive tyrosine kinase inhibitor of ALK — for treatment of patients with metastatic ALK-positive NSCLC who progressed on or are intolerant to crizotinib (Xalkori, Pfizer).”


FDA Grants Genentech’s Alecensa® (Alectinib) Accelerated Approval for People with a Specific Type of Lung Cancer

“Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Alecensa® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. In the pivotal studies, Alecensa shrank tumors in up to 44 percent of people with ALK-positive NSCLC who progressed on crizotinib (objective response rate [ORR] of 38 percent [95 percent CI 28-49] and 44 percent [95 percent CI 36-53]). In a subset of people with tumors that spread to the brain or other parts of the central nervous system (CNS), Alecensa shrank CNS tumors in about 60 percent of people (CNS ORR of 61 percent [95 percent CI 46-74]).”


Prognostic Factors Identified in Patients With ALK‑Rearranged NSCLC and Brain Metastasis

“In a study reported in the Journal of Clinical Oncology, Johung and colleagues identified factors that distinguished survival rates among patients with ALK-rearranged non–small cell lung cancer (NSCLC) and brain metastasis.

“The study included 90 patients from six institutions. Of them, 84 patients had received radiotherapy to the brain, consisting of stereotactic radiosurgery or whole-brain radiotherapy, and 86 patients had received tyrosine kinase inhibitor therapy (crizotinib [Xalkori] in 84 and a second-generation tyrosine kinase inhibitor in 41).”


Pfizer Reports Positive Topline Results from Phase 3 Trial Comparing XALKORI® (crizotinib) to Chemotherapy in Previously Untreated East Asian Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

“Pfizer Inc. announced today that PROFILE 1029, a Phase 3 study of anaplastic lymphoma kinase (ALK) inhibitor XALKORI® (crizotinib), met its primary objective of significantly prolonging progression-free survival (PFS) in previously untreated East Asian patients with ALK-positive advanced non-small cell lung cancer (NSCLC) when compared to a standard chemotherapy doublet. In this study, XALKORI was used as the first systemic therapy for patients with advanced ALK-positive NSCLC, and patients could have received therapy and/or surgery for early stage disease before they were diagnosed with metastatic disease.

“The adverse events observed with XALKORI in the study were generally consistent with findings from previous trials. No unexpected adverse events were observed. Efficacy and safety data from PROFILE 1029 will be submitted for presentation at a future medical meeting.”


FDA Grants Alectinib Priority Review in NSCLC

“Alectinib has received an FDA priority review designation for patients with ALK-positive, locally advanced or metastatic non–small cell lung cancer (NSCLC) who have progressed or are intolerant to crizotinib (Xalkori), according to Genentech, the manufacturer of the oral second-generation ALK inhibitor. The FDA’s action date for an approval decision is March 4, 2016.

“The priority review is based on two phase II trials (NP286731and NP287612) which demonstrated that alectinib had robust activity in patients with ALK-positive NSCLC following progression on crizotinib (Xalkori), including individuals with CNS metastases.

“ ‘Alectinib was granted priority review by the FDA based on results from two studies showing the medicine shrank tumors in people with ALK-positive NSCLC that progressed on crizotinib,’ Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, said in a statement. ‘There is a need for new treatment options in this patient population, especially because the disease often spreads to the brain at progression.’ “


Alectinib Promising in ALK-Positive Advanced NSCLC

“The ALK and RET inhibitor alectinib yielded good response rates and was very well tolerated in a phase II trial of patients with advanced, ALK-positive non–small-cell lung cancer (NSCLC; abstract 8008). Results were presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 29 to June 2, in Chicago.

“Crizotinib is currently the standard-of-care for advanced, treatment-naive ALK-positive NSCLC. ‘However, the median progression-free survival (PFS) for these patients on crizotinib is under 12 months,’ said Sai-Hong Ignatius Ou, MD, PhD, of the UC Irvine Medical Center in California. ‘This is in part due to development of ALK mutations that are resistant to crizotinib.’

“Alectinib is a next-generation inhibitor that is highly selective for ALK and RET; as an ALK inhibitor, Ou said, it is approximately five times as potent as crizotinib. It can inhibit the majority of clinically relevant acquired ALK mutations.”


Novartis Presents New Data at ASCO for Zykadia® and Combination of Tafinlar® and Mekinist® in Certain NSCLC Patients with Unmet Needs

“Novartis today announced new data from two Phase II studies of Zykadia® (ceritinib), as well as one Phase II study of Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) in certain patients with non-small cell lung cancer (NSCLC). Data from these studies were presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

“The results of the Zykadia studies – ASCEND-2 and ASCEND-3 – reinforce the efficacy of the medicine in patients with anaplastic lymphoma kinase-positive (ALK+) NSCLC who had received previous treatment with an ALK inhibitor and in those receiving an ALK-targeted therapy for the first time. Overall response rates (ORR) seen in these trials were 38.6% and 63.7%, respectively, based upon investigator assessment. Comparable ORR results were observed in patients with ALK+ NSCLC who entered the studies with brain metastases (33% and 58%, respectively)[1],[2].

“Separately, the study of dabrafenib in combination with trametinib in patients with metastatic BRAF V600E-mutation positive NSCLC who had failed at least one round of chemotherapy demonstrated an ORR of 63% in this population[3].”